Tethered Capsule Endomicroscopy for Barrett's Esophagus

Palo Alto (17 mi)

Overseen byGuillermo Tearney, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this research is to follow Barrett's Esophagus patients for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

Eligibility Criteria

This trial is for adults over 18 with Barrett's Esophagus (BE) but without severe cell changes or esophageal cancer. Participants must not eat solid food for at least 4 hours and only clear liquids for 2 hours before the procedure. They should be able to swallow capsules, give informed consent, and have had a standard EGD within the past 15 months.

Inclusion Criteria

I have Barrett's esophagus without severe changes or cancer, confirmed by a biopsy.

Exclusion Criteria

I have an esophageal fistula or stricture.

I have had a procedure to remove or destroy Barrett's esophagus.

Treatment Details

The study tests Tethered Capsule Endomicroscopy (TCE), a less invasive way to monitor Barrett's Esophagus using a capsule device with imaging technology. Patients will be followed up for three years at multiple sites to see how well TCE works in detecting changes in the esophagus.

1Treatment groups

Experimental Treatment

Group I: Experimental OFDI capsule imagingExperimental Treatment1 Intervention

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule